Study of Subcutaneous (Injected Under the Skin) Risankizumab to Assess Change in Disease Symptoms in Adult Participants With Moderate to Severe Plaque Psoriasis With Palmoplantar Involvement

Psoriasis Clinical Trial

— IMMprint  

Official title:

IMMprint: A Phase 3b Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating Safety and Efficacy of Risankizumab Compared to Placebo in Adult Subjects With Moderate to Severe Plaque Psoriasis With Palmoplantar (Non-Pustular) Involvement (PPPsO)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04713592
• Other study ID #: M15-994
• Secondary ID: 2020-000581-42
• Status: Completed
• Phase: Phase 3
• Start date: February 26, 2021
• Est. completion date: April 20, 2023

Study information

• Verified date: June 2024
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Plaque Psoriasis is a chronic inflammatory disease in which skin cells build up and develop scaly red and white patches on the skin. It is caused by an overactive immune system where the body attacks healthy tissue by mistake. Palmoplantar (non-pustular) plaque psoriasis (PPPsO) represents a localized form of psoriasis in palms and soles. This study will evaluate how safe risankizumab is for the treatment of plaque psoriasis with palmoplantar involvement and to assess change in disease symptoms.

Risankizumab is an approved drug for the treatment of psoriasis. Study doctors put the participants in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo in Period A. In Period B, all the participants will receive risankizumab. Around 168 adult participants with a moderate to severe plaque psoriasis will be enrolled in approximately 55 sites across the world.

Participants will receive single subcutaneous (administered under the skin) risankizumab or placebo in period A (16 weeks). In period B (36 weeks), all participants will receive subcutaneous risankizumab once every 12 weeks.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: April 20, 2023
• Est. primary completion date: April 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of chronic palmoplantar plaque psoriasis (PPPsO) (with or without psoriatic arthritis) for at least 6 months before Baseline and a Palmoplantar Investigator's Global Assessment (ppIGA) of moderate or severe, at Screening and Baseline.

• Must have at Screening and Baseline a plaque psoriasis (PsO) body surface area (BSA) involvement of greater than or equal to one percent, an Static Physician's Global Assessment (sPGA) score of moderate to severe (greater than or equal to three), a PPASI moderate to severe (greater than or equal to eight), at least one additional PsO plaque outside of the palms and soles.

• Must be a candidate for systemic therapy as assessed by the investigator.

• Previously had inadequately controlled disease by topicals, phototherapy and/or systemic treatments.

Exclusion Criteria:

• History of PsO other than chronic plaque type PsO

• History of current drug-induced PsO or a drug-induced exacerbation of pre-existing psoriasis.

• Ongoing inflammatory skin diseases other than PsO and psoriatic arthritis that could interfere with PsO assessments.

• Evidence of Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, human immunodeficiency virus (HIV), Active tuberculosis, Active systemic infection/clinically important infections in the last two weeks prior to Baseline.

• Prior exposure to risankizumab.

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Placebo for Risankizumab
Subcutaneous (SC) Injection
• Risankizumab
Subcutaneous (SC) Injection

Locations

Country	Name	City	State
Canada	Beacon Dermatology Inc /ID# 220940	Calgary	Alberta
Canada	Dr. Irina Turchin PC Inc. /ID# 220938	Fredericton	New Brunswick
Canada	Innovaderm Research Inc. /ID# 222126	Montréal	Quebec
Canada	Dr. S.K. Siddha Medicine Professional Corporation /ID# 220936	Newmarket	Ontario
Canada	Centre de Recherche dermatologique du Quebec Metropolitain /ID# 220935	Québec	Quebec
Canada	NewLab Clinical Research Inc. /ID# 220934	St. John's	Newfoundland and Labrador
Canada	Dr. Chih-ho Hong Medical Inc. /ID# 220941	Surrey	British Columbia
Canada	Research Toronto /ID# 220939	Toronto	Ontario
Puerto Rico	Dr. Samuel Sanchez PSC /ID# 218789	Caguas
Puerto Rico	Alma M. Cruz Santana, MD-Private practice /ID# 218790	Carolina
Puerto Rico	Pan American Center for Oncology Trials, LLC /ID# 218788	Rio Piedras
Puerto Rico	Clinical Research Puerto Rico /ID# 218787	San Juan
Puerto Rico	GCM Medical Group, PSC /ID# 218786	San Juan
Spain	Hospital Universitario Basurto /ID# 220904	Bilbao	Vizcaya
Spain	Hospital Universitario de la Princesa /ID# 224911	Madrid
Spain	Hospital Universitario Ramon y Cajal /ID# 220908	Madrid
Spain	Hospital Regional Universitario de Malaga /ID# 220900	Malaga
Spain	Hospital Universitario Virgen del Rocio /ID# 220907	Sevilla
Spain	Hospital General Universitario de Valencia /ID# 220898	Valencia
Spain	Hospital Universitario y Politecnico La Fe /ID# 220903	Valencia
Spain	Hospital Clinico Universitario Lozano Blesa /ID# 222492	Zaragoza
United States	Hamilton Research, LLC /ID# 219224	Alpharetta	Georgia
United States	David Fivenson, MD, PLC /ID# 219180	Ann Arbor	Michigan
United States	Colorado Center for Dermatology, PLLC /ID# 219223	Centennial	Colorado
United States	ClinOhio Research Services /ID# 222298	Columbus	Ohio
United States	Menter Dermatology Res Inst /ID# 219161	Dallas	Texas
United States	Henry Ford Medical Center /ID# 219205	Detroit	Michigan
United States	Velocity Clinical Research-Providence /ID# 223350	East Greenwich	Rhode Island
United States	Psoriasis Treatment Center of Central New Jersey /ID# 219201	East Windsor	New Jersey
United States	Palmetto Clinical Trial Services /ID# 222275	Fountain Inn	South Carolina
United States	Palmetto Clinical Trial Services /ID# 222299	Fountain Inn	South Carolina
United States	Advanced Research Associates - Glendale /ID# 219197	Glendale	Arizona
United States	Skin Care Research - Hollywood /ID# 219184	Hollywood	Florida
United States	Burke Pharmaceutical Research /ID# 223349	Hot Springs	Arkansas
United States	Center for Clinical Studies - Houston (Binz) /ID# 219221	Houston	Texas
United States	Dawes Fretzin, LLC /ID# 219219	Indianapolis	Indiana
United States	Forest Hills Dermatology Group /ID# 219200	Kew Gardens	New York
United States	Dermatology Research Associates /ID# 219195	Los Angeles	California
United States	GSI Clinical Research, LLC /ID# 219175	Margate	Florida
United States	Allcutis Research LLC /ID# 222272	Methuen	Massachusetts
United States	Savin Medical Group, LLC /ID# 227754	Miami Lakes	Florida
United States	International Clinical Research - Tennessee LLC /ID# 220930	Murfreesboro	Tennessee
United States	The Dermatology Center PSC - New Albany /ID# 219183	New Albany	Indiana
United States	Icahn School of Medicine at Mount Sinai /ID# 219206	New York	New York
United States	Virginia Clinical Research, Inc. /ID# 219181	Norfolk	Virginia
United States	Advanced Dermatology of the Midlands /ID# 219207	Omaha	Nebraska
United States	Epiphany Dermatology of Kansas LLC /ID# 219208	Overland Park	Kansas
United States	University of Pittsburgh MC /ID# 219203	Pittsburgh	Pennsylvania
United States	NW Arkansas Clinical Trials Center /ID# 231602	Rogers	Arkansas
United States	Arlington Dermatology /ID# 219211	Rolling Meadows	Illinois
United States	Integrative Skin Science and Research /ID# 219216	Sacramento	California
United States	Advanced Clinical Research - Woseth Dermatology /ID# 224750	Salt Lake City	Utah
United States	Medderm Associates /ID# 219210	San Diego	California
United States	Northshore University Health System Dermatology Clinical Trials Unit /ID# 219220	Skokie	Illinois
United States	Lenus Research & Medical Group /ID# 219202	Sweetwater	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Canada,  Puerto Rico,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving Palmoplantar Investigator's Global Assessment (ppIGA) of "Clear" or "Almost Clear" (0 or 1) With at Least a 2-point Reduction From Baseline at Week 16	The ppIGA is a 5-point score ranging from 0 to 4, based on the investigator's assessment of the average erythema (redness), induration (thickness), and scaling of all palmoplantar (non-pustular) psoriatic lesions. A lower score indicates lower severity, with 0 being "clear" and 1 being "almost clear."	Baseline, Week 16
Primary	Number of Participants With Treatment-Emergent Adverse Events	An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.	From the first dose of study drug in the Double-blind Period up to 140 days after the last dose; from the first dose of study drug in the Open-label Period up to 140 days after the last dose and the end of study date (up to 60 weeks)
Secondary	Percentage of Participants Achieving = 75% Improvement From Baseline in Palmoplantar Psoriasis Area and Severity Index (PPASI 75) Response at Week 16	PPASI is a linear combination of percent of surface area of hands and feet that are affected and the severity of erythema, induration, and desquamation with scores ranging from 0 to 72. Higher scores indicate more severe disease.	Baseline, Week 16
Secondary	Percentage of Participants Achieving = 90% Improvement From Baseline in Palmoplantar Psoriasis Area and Severity Index (PPASI 90) Response at Week 16	PPASI is a linear combination of percent of surface area of hands and feet that are affected and the severity of erythema, induration, and desquamation with scores ranging from 0 to 72. Higher scores indicate more severe disease.	Baseline, Week 16
Secondary	Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) of "Clear" or "Almost Clear" (0 or 1) With at Least a 2-point Reduction From Baseline at Week 16	sPGA is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. Higher scores indicate more severe disease.	Baseline, Week 16
Secondary	Percentage of Participants Achieving 100% Improvement From Baseline in Palmoplantar Psoriasis Area and Severity Index (PPASI 100) Response at Week 16	PPASI is a linear combination of percent of surface area of hands and feet that are affected and the severity of erythema, induration, and desquamation with scores ranging from 0 to 72. Higher scores indicate more severe disease.	Baseline, Week 16

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